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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contammation between patient and examiner.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed study data for a novel device. Therefore, much of the requested information about study design, sample sizes, and expert adjudication for an AI/algorithm-based device is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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Powder free vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powder free vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

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Powdered vinyl patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device